(35 days)
The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.
Niveous Liquid Dam is a light-cured resin used for soft tissue isolation/protection during teeth whitening procedures. The material is dispensed from a syringe into the gingival crest just shy of the tooth structure. The resin is light-cured (polymerized) on the soft tissue by exposure for 20 seconds per section of material.
This submission is for a Class II medical device, Niveous Liquid Dam, intended to protect soft tissue during in-office bleaching. It is a 510(k) premarket notification, which means the device's acceptance criteria are centered on demonstrating substantial equivalence to a predicate device, rather than proving novel performance metrics through a clinical study with acceptance criteria.
Therefore, the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and MRMC studies, as typically found in clinical trials for novel devices with performance claims, is not applicable in this 510(k) summary. The "study" for this device is the comparison of its characteristics to a legally marketed predicate device to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence, formal quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance metrics (e.g., exact measured diagnostic accuracy) in a clinical study are not provided in this document. The "acceptance criteria" are based on demonstrating comparable characteristics and intended use to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicate devices for its intended use.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison to predicate) |
|---|---|
| Intended Use: Protect soft tissue during in-office bleaching | Identical Intended Use: "The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching." (Page 1 and 5) |
| Technological Characteristics: Similar chemical composition and physical/chemical characteristics to predicate devices. | "The chemical composition is comparable to FastDam, 510(k) K972775, and has the same physical and chemical characteristics." This implies the device meets the performance characteristics of the predicate, though specific numerical values are not reported. (Page 2) |
| Biocompatibility: Safe for soft tissue contact. | "Niveous Liquid Dam is similar in use and formulation to other dental dams that have been on the market for several years... The formulation does not contain any new or non-conventional chemicals; therefore, new biocompatibility testing is unwarranted." This indicates comparable biocompatibility to established devices. (Page 2) |
| Safety and Effectiveness: No new questions of safety or effectiveness raised. | The FDA's clearance (K021613) implies that no new questions of safety or effectiveness were raised relative to the predicate devices. (Page 3) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No "test set" in the sense of a clinical trial dataset with patient samples was used for this 510(k) submission as it focuses on substantial equivalence based on material properties and intended use.
- Data Provenance: Not applicable for a traditional clinical "test set." The data provenance for the comparison is the existing regulatory files and market history of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
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Number of Experts: Not applicable. No external experts were used to establish ground truth for a clinical test set as part of this submission. The "ground truth" for substantial equivalence is based on the known characteristics and approved status of the predicate devices.
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Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No formal adjudication method for a clinical test set was employed as part of this 510(k) submission.
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
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MRMC Study: No. This device is a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
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Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness profile, chemical composition, physical characteristics, and intended use of the legally marketed predicate devices (FastDam [K972775] and OpalDam [K971284]). The applicant demonstrated that Niveous Liquid Dam is sufficiently similar to these predicates.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a dental material, not an AI/machine learning algorithm, so there is no "training set" in that context. The development of the material would involve internal R&D and quality control, but not a "training set" as understood in AI studies.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. As there is no AI training set, this question is not relevant.
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.