(405 days)
Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.
EDS Calculus Softener (TURBO-CR™) is a professional use only product to be used by a dental hygienist to aid in the cleaning and removal of dental plaque, mineralized calculus and/or tartar from subgingival root surfaces and supragingival areas of teeth. The composition helps remove the etiological factors which have been implicated in fostering periodontal disease. The device contains chelating agents and detergents which reduce the hardness of mineralized plaque, calculus, and/or tartar. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. The device contains an alkaline paste which effervescences or foams upon mixing through a mixing tip. This effervescence helps drive the activated composition into the "hard to reach" interproximal spaces between teeth as into the subgingival regions where tartar/plaque and or dental calculus can accumulate.
It is packaged in the familiar double-barrel syringe configuration used by numerous other dental materials. The double barrel syringe is placed into a manual cartridge gun (commonly available at the dental clinic) and the composition is dispensed into a dental tray which is then placed over the patient's dental arch for cleaning. The steps required to properly express the calculus softening composition are: remove cap, attach mixer, place into manual cartridge gun, express the material into a dental tray, and then place into the patient's mouth over the dental arch to be cleaned/debrided for 60 seconds. The patient is then instructed to rinse and the dental scaling can commence by the dental hygienist. After use, the mixer/dispensing tip and dental tray should be discarded and the cap replaced. The device is provided non-sterile and does not contain fluoride or any whitening agents.
The provided text is a 510(k) premarket notification for the EDS Calculus Softener (TURBO-CR™). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication as one might see for a novel AI/imaging device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth establishment, adjudication methods, MRMC studies, or effect size of human reader improvement with AI assistance, are not applicable to this type of submission. This document describes a new medical device and demonstrates its equivalence to existing, legally marketed devices, primarily through bench testing and comparison of characteristics, rather than a clinical trial demonstrating a novel performance claim that would require an AI-style evaluation.
Here's an attempt to answer the questions based on the provided text, highlighting where information is N/A or not relevant to this submission type:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical targets (e.g., "softening of calculus by X%"). Instead, the performance objective is to demonstrate that the device is substantially equivalent to the predicate device in its ability to soften simulated dental calculus and meets relevant safety standards.
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Safety: | |
| Biocompatibility (cytotoxicity, irritation/sensitization) per ISO standards | "The results of the biocompatibility testing shows that the EDS Calculus Softener (TURBO-CR™) is safe for the intended use and does not elicit any adverse reactions while exhibiting excellent tolerance by the mucosal tissue." (Conducted according to ISO 7405:2018, ISO 10993-1:2018, ISO 10993-5:2009/(R)2014, ISO 10993-10:2010/(R)2014) |
| Performance: | |
| Softening of simulated dental calculus (via Microindentation Hardness) | "Softening of simulated dental calculus via Microindentation Hardness of Materials testing (ASTM E384-22)" was performed. While specific numerical results are not provided in this summary, the submission states that the verification and validation testing was "acceptable and supports the claims of substantial equivalence." |
| pH | "pH - ISO 11609:2017" was performed. Results not explicitly stated in this summary, but deemed acceptable for substantial equivalence. |
| Viscosity | "Viscosity ISO 3219-2:2021" was performed. Results not explicitly stated in this summary, but deemed acceptable for substantial equivalence. |
| Comparison of characteristics to predicate devices (composition, intended use, etc.) | The device is deemed "substantially equivalent" to the primary predicate device (SofScale, K903163) and a reference predicate device (Therasol Tartar Dissolver, 510k exempt) in terms of performance, indications for use, instructions for use, chemical mode of action, and biocompatibility. Differences (e.g., two-component effervescing gel vs. single gel) are addressed as not raising questions regarding safety and effectiveness. The principal composition (chelating agents) is comparable, and components are either identical to predicates or found in legally marketed devices/GRAS database. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human data or a specific "test set" for a novel algorithm. The testing described (bench and biocompatibility) is for the physical and chemical properties of the device itself. For example, for ASTM E384-22 (Microindentation Hardness), a sample of the material would be tested, not patient data. The document does not specify the number of material samples used for these bench tests.
- Data Provenance: Not applicable for device material testing. There is no patient data involved in the described equivalence testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth in this context is established through standardized laboratory tests (e.g., pH meter readings, viscometer measurements, hardness measurements) and adherence to international ISO and ASTM standards for biocompatibility and material properties. It does not involve human expert interpretation of images or clinical outcomes.
- Qualifications of Experts: N/A for human experts establishing ground truth. The testing is performed by laboratory personnel following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As there are no human expert interpretations requiring consensus or adjudication, this step is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- MRMC Study: No. This type of study is typically performed for AI-assisted diagnostic tools where human reader performance is being evaluated with and without AI. This submission is for a physical/chemical dental product used by a hygienist, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Standalone Performance: Not applicable. This is not an AI algorithm. The performance testing is for the physical and chemical properties of the gel.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for performance is established by objective measurements following standardized laboratory protocols (e.g., ASTM E384-22 for microindentation hardness, ISO 11609:2017 for pH, ISO 3219-2:2021 for viscosity) and biocompatibility testing against ISO standards (e.g., ISO 10993 series for cytotoxicity, irritation/sensitization). The foundational "ground truth" for the device's safety and effectiveness relies on the long history of safe clinical use of the predicate devices and the generally recognized as safe (GRAS) status of many of its components.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.