(112 days)
The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. These indications are the same as those claimed for the predicate device.
The Roeko Dental Dam Silicone. Its common name is dental dam and the classification name is Rubber dam and accessories. The Roeko dam is a silicone product used in dental procedures. The device consists of a 150 mm x 150 mm green opaque film of less than 1mm in thickness. The device is available with frame, clamp and other accessories for use in dental procedures.
This 510(k) summary (K961472) is for a dental dam, and as such, the information provided is very limited in the context of advanced AI/medical imaging device studies. It focuses on demonstrating substantial equivalence to an existing device rather than presenting performance metrics from a detailed study.
Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text. I will address the applicable points and indicate where information is missing.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" are implicitly tied to the substantial equivalence to the predicate device (Hygienic brand latex dam) in terms of physical properties and biocompatibility.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Comparable physical properties (specifically elongation) to latex | "The technological characteristics in terms of physical properties, particularly elongation, are comparable to latex" |
| Acceptable biocompatibility | "Biocompatibility tests indicate that Roeko Dental Dam Silicone does not show significantly adverse biological responses." |
| Device is safe, effective, and performs as well or better than predicate device | "In view of the above, the device is as safe, as effective and performs as well or better than the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document mentions "biocompatibility tests" and "technological characteristics" but does not detail the sample sizes or the specifics of these tests (e.g., in vitro, in vivo, a particular patient population, or the origin of any data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a physical dental dam. "Ground truth" in the context of expert consensus for diagnostic tasks is not relevant here. The evaluation relies on physical and chemical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the case for a physical device like a dental dam.
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 information is not applicable. The device is a physical dental dam, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This refers to AI algorithm performance, which is not relevant for a physical dental device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical and chemical properties, the "ground truth" would be established by standardized laboratory testing and measurements based on established engineering and materials science principles. For biocompatibility, it would be based on recognized biocompatibility testing standards (e.g., ISO 10993 series) and their respective endpoints.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of AI model development for a physical device like a dental dam. The manufacturing processes and material specifications are developed through engineering and materials science, not machine learning training.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of AI. The "ground truth" for the device's characteristics (material properties, biocompatibility) would be established through laboratory testing and adherence to relevant industry standards.
§ 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.