(84 days)
Bite registration
Intraoral guide pin excursion tracing
DIMENSION® BITE is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.
DIMENSION® BITE is similar in intended use and substantially equivalent to Roydent's polyvinyl siloxane based impression and bite registration material PANASIL® and ESPE's polyvinyl siloxane based impression material DIMENSION® PENTA.
The composition of the new DIMENSION® BITE contains the same ingredients as ESPE's DIMENSION® PENTA® impression material except one softening agent which is contained in ESPE's polyether based impression material PERMADYNE® GArant®.
This document describes a 510(k) submission for a dental impression material named DIMENSION® BITE. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as would typically be found for AI/software-as-a-medical-device (SaMD).
Therefore, many of the requested categories for a SaMD study are not applicable or cannot be extracted from the provided text. The submission relies on comparing physical and mechanical properties, not an AI algorithm's performance.
Here's the information that can be extracted or derived from the provided text, with explanations where categories are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (impression material), substantial equivalence is demonstrated by comparing the physical and mechanical properties of the new device to a legally marketed predicate device. While specific quantitative acceptance criteria are not explicitly listed in the provided text (like a specific tensile strength value that must be met), the acceptance criterion is implicitly that the new device's properties are comparable or equivalent to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Physical and mechanical properties comparable to predicate device. | "The physical and mechanical properties of the new DIMENSION® BITE have been compared to those of the old DIMENSION® BITE (FUTAR® OCCLUSION)." |
| Same intended use as predicate device. | "DIMENSION® BITE is similar in intended use and substantially equivalent to Roydent's polyvinyl siloxane based impression and bite registration material PANASIL®..." |
| Safe and effective. | "The above mentioned impression and bite registration materials are well established and considered to be safe and effective." |
2. Sample Size Used for the Test Set and the Data Provenance
This information is typically relevant for studies involving data-driven algorithms or diagnostic tests. For a physical material comparison, "test set" in the traditional sense of a dataset for an algorithm is not applicable. The comparison was likely performed on samples of the manufactured material. The text does not provide specific sample sizes for the physical/mechanical property testing or data provenance for these tests (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in this context refers to a clinically validated reference standard for an algorithmic decision. For an impression material, the "ground truth" of its properties would be determined by laboratory testing measurements, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human annotators or readers in studies where a definitive "ground truth" is established through human interpretation. This is not relevant for an impression material's physical 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
Not applicable. This is not a study involving human readers or AI assistance. It's a comparison of a physical dental material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no algorithm involved in this device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for demonstrating substantial equivalence is based on objective measurements of physical and mechanical properties (e.g., tensile strength, tear strength, dimensional stability, viscosity, working time, setting time) in a laboratory setting, compared to the predicate device. The text itself doesn't detail these specific property measurements, but states they were compared.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this device.
§ 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).