(183 days)
The Doc's Best White Copper Cement is intended for use in luting of all types of restorations (e.g., ceramic, composition, metal) inclusive of bridges and crowns, inlays and onlays, attachments, pins and posts, orthodontic appliances, and cavity liners and primary teeth cavity fillings.
The Doc's Best White Copper Cement is a powder that is mixed with an approved aqueous liquid to form a self-curing adhesive cement. The cement is used in the luting of restoration of bridges and crowns, orthodontic appliances as well as cavity liners and primary teeth cavity fillings. The product is provided as a two-part product requiring mixing prior to use.
The provided document does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for a medical device with performance metrics.
This document is a 510(k) premarket notification for a dental cement (Doc's Best White Copper Cement). For this type of device, substantial equivalence is claimed based on comparing it to legally marketed predicate devices, not typically through a study demonstrating specific performance metrics against pre-defined acceptance criteria.
The key points from the provided text are:
- Substantial Equivalence: The applicant is claiming substantial equivalence to existing dental cements (Doc's Best Red Copper Cement, 3M Vitremer Luting Cement, etc.)
- Indications for Use: The new device shares the same intended uses as the predicate devices (luting various restorations, orthodontic appliances, cavity liners, primary teeth fillings).
- Technological Characteristics: The device has "similar technological and chemical characteristics" to the predicate devices.
- Performance and Safety: Cooley & Cooley, Ltd. "has provided performance and safety documentation in conformance with FDA requirements provided in the quidance documents entitled "Dental Cements - Premarket Notification" (issued August 1998)." This refers to general compliance with existing guidance for dental cements, not a specific performance study with pre-defined acceptance criteria for this new device.
- No New Issues: The conclusion states the device "performs as intended and does not raise any new safety or efficacy issues."
Therefore, I cannot populate the requested table or answer most of the questions relating to a specific performance study because the document does not describe one.
Here's how I would address your request based only on the provided text, highlighting the lack of information for most points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The device's performance is not evaluated against specific quantitative "acceptance criteria" in this 510(k). The basis for clearance is "substantial equivalence" to predicate devices. | The document states, "Doc's Best White Copper Cement performs as intended and does not raise any new safety or efficacy issues." This is a qualitative statement of overall performance without specific metrics. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. No specific test set or study with a sample size is described in the document.
- Data provenance: Not applicable. There is no described study from which to determine data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set
- Not applicable. No adjudication method for a test set is described.
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. This device is a dental cement, not an AI-powered diagnostic tool. An MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a dental cement, not an algorithm.
7. The type of ground truth used
- Not applicable. No specific ground truth for performance evaluation of this new device is described. The "ground truth" for demonstrating safety and efficacy in a 510(k) for a dental cement typically relies on established performance of predicate devices and adherence to relevant industry standards and guidance documents, rather than a clinical ground truth like pathology or outcomes data for a new device study.
8. The sample size for the training set
- Not applicable. This document describes a physical dental cement, not a machine learning model with a training set.
9. How the ground truth for the training set was established
- Not applicable. No ground truth for a training set is described.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.