(4 days)
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.
The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
The provided 510(k) summary for BriteSmile Masking Cream focuses on establishing substantial equivalence to a predicate device through various tests rather than setting specific acceptance criteria with performance metrics. Therefore, explicit "acceptance criteria" in the format of a performance table are not available in the document.
The document highlights the types of studies conducted to demonstrate safety and performance but does not provide quantitative results or detailed methodologies that would typically be associated with performance acceptance criteria for a medical device that produces a measurable output (e.g., diagnostic accuracy, sensitivity, specificity).
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have met relevant biocompatibility standards. |
| Functionality | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have met functional requirements (e.g., effective heat reduction). |
| Shelf Life | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have met specified shelf-life requirements. |
| Antimicrobial Properties | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have demonstrated appropriate antimicrobial characteristics. |
Missing Information: The document does not specify quantitative acceptance criteria (e.g., "biocompatibility shall meet ISO 10993 cytotoxicity limits") nor does it provide quantitative performance results (e.g., "cytotoxicity score of X"). It only states that testing was completed to validate safety and performance.
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the tests (biocompatibility, functionality, shelf life, antimicrobial). It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Dental product studies often involve human subject testing or in vitro/ex vivo testing, but no details are provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided. The product is a masking cream, and its performance is evaluated through technical and biological tests rather than interpretation or diagnosis by experts.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The nature of the studies (biocompatibility, functionality, etc.) does not typically involve adjudication like in diagnostic imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret results, which is not the case for a masking cream.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study in the context of an algorithm or AI was conducted or mentioned. The device is a physical product (masking cream), not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the tests mentioned (biocompatibility, functionality, shelf life, antimicrobial) would be established by:
- Biocompatibility: Adherence to established biocompatibility standards (e.g., ISO 10993 series) and specific test results (e.g., non-cytotoxic, non-irritating).
- Functionality: Demonstrating the ability to reduce heat transmission and protect soft tissue as intended. This might involve thermal measurements or clinical observations.
- Shelf Life: Stability testing to ensure the product maintains its properties over its declared shelf life.
- Antimicrobial: Standard microbiological testing to evaluate antimicrobial efficacy or resistance to microbial growth.
The document does not detail the specific methodology for establishing these "ground truths."
8. Sample Size for the Training Set:
This information is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided, as there is no training set for this type of device.
Summary of Available Information:
The 510(k) summary for BriteSmile Masking Cream emphasizes that safety and performance were validated through standard design control procedures, including biocompatibility, functionality, shelf life, and antimicrobial testing. However, it does not provide specific quantitative acceptance criteria or detailed results of these tests. The nature of the device (a masking cream) means that many of the requested categories related to expert interpretation, AI, or diagnostic performance are not applicable.
§ 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.