(112 days)
The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.
The OSspray Cleaning Compound is a biocompatible calcium sodium phosphosilicate compound in powder form intended for cleaning and polishing procedures as part of a dental prophylaxis treatment to remove debris from tooth surfaces. The OSspray Cleaning Compound is also intended to physically occlude dentin tubules to provide relief from tooth sensitivity during the prophylaxis treatment. The process of cleaning the tooth surface with the OSspray Cleaning Compound physically occludes dentin tubules for the management of sensitive teeth. The OSspray Cleaning Compound is a dry inorganic particulate (calcium sodium phosphosilicate) composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, the OSspray Cleaning Compound undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles of the compound react to form hydroxycarbonate apatite (HCA), which is chemically similar to natural tooth mineral.
The provided text describes the OSspray Cleaning Compound, a product intended for dental cleaning, polishing, and relief from tooth sensitivity. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC).
The document focuses on:
- Device description and intended use.
- Comparison to predicate devices (Prophy Powder and BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN) for substantial equivalence based on technological characteristics.
- Biocompatibility testing (cytotoxicity, intracutaneous irritation, maximization sensitization tests) according to ISO 10993.
- Tubule occlusion efficacy evaluation using an in vitro dentin block model.
The device's performance is discussed in terms of biocompatibility and in vitro efficacy for tubule occlusion, not in terms of traditional statistical performance metrics like sensitivity, specificity, or reader studies which are typically associated with diagnostic or AI/ML-driven devices.
Therefore, I cannot populate the requested table and answer many of the specific questions as the information is not present in the provided text.
Here's an attempt to answer what can be inferred from the text, with clear indications where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from study types) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity (L-929) | Met ─ device is biocompatible and safe. |
| - Intracutaneous Irritation | Met ─ device is biocompatible and safe. |
| - Maximization Sensitization | Met ─ device is biocompatible and safe. |
| Tubule Occlusion Efficacy: | |
| - Statistically significant tubule occlusion compared to controls | Achieved ─ statistically significant tubule occlusion compared to both positive and negative controls. |
2. Sample size used for the test set and the data provenance:
- Biocompatibility tests: Sample sizes are not specified for L-929 cytotoxicity, intracutaneous irritation, or maximization sensitization tests.
- Tubule occlusion study: The sample size for the in vitro dentin block model is not specified.
- Data provenance: Not explicitly stated, but assumed to be from internal lab studies by OSspray Ltd. given the context of a 510(k) submission. No mention of country of origin for data; studies are likely conducted by or for the manufacturer. The studies are in vitro in nature, not retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The tests described are laboratory-based (biocompatibility, in vitro tubule occlusion) and do not involve human expert interpretation for establishing ground truth in the way a diagnostic imaging study would. The ground truth for biocompatibility is determined by standardized protocols (ISO 10993) and for tubule occlusion by quantitative microscopic analysis.
4. Adjudication method for the test set:
- Not applicable. This concept pertains to resolving discrepancies among multiple readers or experts in studies involving human interpretation. The described studies are laboratory-based.
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. An MRMC study was not done. This device is not an AI/ML diagnostic tool, and its performance is not assessed in terms of human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially applicable, but for a different context. The tubule occlusion efficacy study and biocompatibility tests can be considered "standalone" in the sense that they assess the device's inherent physical/chemical performance, not its interaction or assistance with a human operator's diagnostic capabilities. However, this is not in the context of an "algorithm" or AI.
7. The type of ground truth used:
- Biocompatibility: Standardized test protocols (ISO 10993) where "ground truth" is defined by the absence of toxicity, irritation, or sensitization.
- Tubule occlusion: Quantitative measurement of occluded tubules using microscopy in an in vitro dentin block model. The "ground truth" is the objective measurement itself.
8. The sample size for the training set:
- Not applicable. This device is a physical compound, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(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 the limitations in § 872.9.