(53 days)
Porta IP Solder V-2 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions.
Porta IP Solder V-2 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with very high contents of precious metals (Gold, Platinum, Iridium and Silver: 99,4%). Porta IP Solder V-2 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as solder before firing for dental ceramic alloys with appropriate melting ranges and compositions, especially Porta Geo Ti, Porta SMK 82, Portalloy 54, and Simidur S1S and Simidur KF plus, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta IP Solder V-2 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
This document is a 510(k) premarket notification for a dental brazing alloy called "Porta IP Solder V-2". The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against acceptance criteria through a specific study as you might find for novel clinical diagnostic or therapeutic devices.
Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not typically present in this type of submission for this class of device.
Here's why and what information is available:
- Device Type: Porta IP Solder V-2 is a dental brazing alloy. These are often classified as Class II devices, and their performance is primarily assessed through compliance with recognized standards and comparison to a predicate device.
- 510(k) Purpose: The 510(k) process demonstrates "substantial equivalence" to a predicate device already on the market. It does not typically require extensive clinical trials or complex performance studies like those for AI/ML-driven diagnostic devices.
- Predicate Device: The predicate device is "Argesol 600" (510(k) number: K954360). The submission aims to show that Porta IP Solder V-2 is as safe and effective as Argesol 600.
Regarding the specific questions you asked:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The primary acceptance criterion for this type of device in a 510(k) context is "substantial equivalence" to the predicate device and compliance with relevant standards. The document states: "Porta IP Solder V-2 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."
- Reported Device Performance: The document describes the device's properties (yellow alloy, high precious metal content, suitable for joining dental alloy parts, intended as solder before firing for specific ceramic alloys). It doesn't present quantitative performance data against specific, pre-defined acceptance criteria in the way a diagnostic algorithm might (e.g., sensitivity, specificity thresholds). Instead, the performance is implicitly linked to its composition, intended use, and compliance with standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. Performance studies with test sets in the context you're describing are not detailed for this type of chemical-mechanical dental material in a 510(k) summary.
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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 information is not provided and is not relevant for this type of device. "Ground truth" in the context of expert consensus is typically associated with diagnostic or image-based devices, not dental alloys.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is not relevant for this type of device.
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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 information is not provided and is completely irrelevant as this is a dental alloy, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not provided and is completely irrelevant as this is a dental alloy, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not provided and is not relevant in the traditional sense for this type of device. "Ground truth" for a dental alloy would relate to its material properties and clinical performance, likely assessed through physical and chemical testing and clinical outcomes, but not described in detail here in a 510(k) summary.
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The sample size for the training set:
- This information is not provided and is not relevant for this device. "Training sets" are used for machine learning models.
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How the ground truth for the training set was established:
- This information is not provided and is not relevant for this device.
In summary:
This document is a regulatory submission for a dental alloy. The "study" referenced in the context of substantial equivalence is the comparison to a legally marketed predicate device and demonstrating compliance with international and European standards for dental materials. It does not involve the detailed performance studies, expert reviews, or AI/ML evaluations that your questions imply for a different category of medical device.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.