(98 days)
Speedex putty/putty soft
- Primary impression in the putty-wash Impression technique
- Pick-up impression in the simultaneous mixing technique
- Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses
Speedex light body - Correction material for the correction impression technique
- Syringe material for the two-phase impression technique
- Impression material for relining
Speedex medium - Complete and partial prosthetics, correction material for the correction impression technique
- Monophase impression technique, simultaneous mixing technique
- Liner impression material
Speedex Universal Activator - Activator for Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions
Speedex is two-component impression material based on polysiloxanes. Speedex is intended for the recording of the current physical situation in a patient's mouth for the purpose of repairing, reshaping or replacing the patient's teeth. After mixing of a base and activator, the Speedex Materials form pastes which are used individually or in combination as antal impression material, usually together with a standard commerical or individual impression tray, using conventional impression techniques.
The provided text is a 510(k) premarket notification letter and summary for a dental impression material named "Speedex." This document does not describe an AI/ML-based medical device. Therefore, a study proving an AI device meets acceptance criteria, an MRMC study, or information about training and test sets for an algorithm, as requested in the prompt, are not applicable and not present in the provided text.
The document discusses the substantial equivalence of the Speedex dental impression material to a legally marketed predicate device ("PRESIDENT The Original"). Acceptance criteria and performance are outlined in the context of non-clinical performance testing for material properties, rather than AI/ML model performance.
Here's an analysis of the provided information relevant to the material's acceptance criteria and study, as much as possible given the context:
1. A table of acceptance criteria and the reported device performance:
The document states: "Performance testing as was conducted to verify that the device complies with the requirements of ISO 4823:2021, and the same testing was carried out on the predicate device to help establish substantial equivalence. These tests include consistency, working time, detail reproduction, linear dimensional change, compatibility with gypsum, elastic recovery, and strain in compression."
While the specific numerical acceptance criteria and reported performance values are not explicitly provided in tables, the document implies that the Speedex device met the requirements of ISO 4823:2021 for these properties. The "Summary & Conclusions" section states: "Based on the non-clinical performance data, the proposed device Speedex is as safe, as effective and performs as well as the predicate Device PRESIDENT the Original." This statement confirms that the device did meet its performance requirements to demonstrate substantial equivalence.
As the exact table is not in the text, it cannot be constructed, but the types of criteria are listed.
2. Sample size used for the test set and the data provenance:
For non-clinical performance testing of a material, "sample size" typically refers to the number of specimens tested for each property (e.g., number of impression material samples tested for linear dimensional change). This information is not provided in the document.
Data provenance (country of origin, retrospective/prospective) is not applicable in the context of material property testing as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable as the testing is for fundamental material properties against an ISO standard, not for medical image interpretation or diagnostic performance involving expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for material property testing.
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:
This is not applicable as the device is a dental impression material, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a dental impression material, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is compliance with ISO 4823:2021 standards for dental impression materials, and comparison to the predicate device's performance for substantial equivalence. No patient outcomes data or expert consensus on a diagnostic task is used.
8. The sample size for the training set:
This concept is not applicable as this is a physical material, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable as this is a physical material, not an AI model.
In summary, the provided document pertains to a traditional medical device (dental impression material) and its non-clinical performance testing against an international standard (ISO 4823:2021) to establish substantial equivalence. The detailed questions about AI/ML acceptance criteria, ground truth, and study designs for AI (like MRMC or standalone performance) are not relevant to this type of device and thus not present in the text.
§ 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).