(270 days)
armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.
The provided FDA 510(k) summary for the Mavrik Dental Systems Ltd.'s armor LC™ device does not include the detailed acceptance criteria or the study data proving the device meets those criteria for the specific performance tests listed. The document generally states that the device "functioned as intended and met the pre-defined acceptance criteria" for each test.
Therefore, many of the requested details cannot be extracted from this document. However, based on the information provided, here's what can be stated:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria (Not explicitly stated for each test) | Reported Device Performance (General Statement) |
|---|---|---|
| Appearance and handling | N/A | Functioned as intended, met pre-defined criteria |
| Removal in one piece | N/A | Functioned as intended, met pre-defined criteria |
| Curing temperature | N/A | Functioned as intended, met pre-defined criteria |
| Sensitivity to ambient light | N/A | Functioned as intended, met pre-defined criteria |
| Viscosity | N/A | Functioned as intended, met pre-defined criteria |
| Depth of cure | N/A | Functioned as intended, met pre-defined criteria |
| Flexural strength | N/A | Functioned as intended, met pre-defined criteria |
| Biocompatibility (Cytotoxicity) | Met ISO 10993-5 (Uncured: 5 min exposure; Cured: 48 hr elution) | Found to be biocompatible |
| Biocompatibility (Irritation & Sensitization) | Met ISO 10993-10 (Uncured: 4 hr; Cured: 7 days) | Found to be biocompatible |
| Biocompatibility (Dentistry specific) | Met ISO 7405 | Found to be biocompatible |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the performance tests.
- Data Provenance: The studies were "Mavrik Dental Systems conducted several performance tests," implying they were conducted by the manufacturer. The document does not specify the country of origin, but the applicant's address is Israel. The tests are "Non-Clinical Performance Data" and "Bench Performance Testing," indicating they are likely laboratory-based studies rather than retrospective or prospective clinical studies involving human patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a non-clinical bench testing and biocompatibility study, not a study requiring expert readers for ground truth establishment.
4. Adjudication method for the test set:
- Not applicable as this is a non-clinical bench testing and biocompatibility study.
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 an AI-assisted device, nor does the document describe an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance described is for the device itself (a light-cured resin dam).
7. The type of ground truth used:
- For Bench Performance Testing: The "ground truth" would be the pre-defined acceptance criteria based on engineering specifications and comparison to predicate devices, but these specific criteria are not detailed in the document.
- For Biocompatibility: The "ground truth" or standard for acceptance was compliance with specific international consensus standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 7405).
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable as there is no training set for this device.
§ 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.