(108 days)
Transport II offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.
Portable Electrical Dental System that combine an autoclavable micro motor, dental irrigation, high and low volume suction and Ultrasonic scaler into a single transportable carrying case into which all features have been integrated.
The provided text describes a 510(k) summary for a dental operative system, not a study involving AI or complex performance metrics. Therefore, many of the requested categories for acceptance criteria and study details are not applicable as this is a traditional medical device submission focused on substantial equivalence to a predicate device.
Here's an analysis based on the provided text, indicating where information is present or not applicable:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way one would for an AI/CADe system with performance metrics like sensitivity, specificity, or AUC. Instead, it focuses on substantial equivalence to predicate devices and compliance with safety standards.
| Criterion | Reported Device Performance / Compliance |
|---|---|
| Electrical and Mechanical Safety (Handpiece Drive System) | Complies with IEC 601.1. Tested and listed under UL 2601.1 (UL File number E208087). |
| Irrigation and Suction System Equivalence | Substantially equivalent to previously marketed device "Asepti-mini" ADU-10 (K905401). |
| Material Compatibility (Water/Wastewater lines, Containers) | Made of polyethylene or polyurethane (lines), PET or Polypropylene (containers). Materials are commonly used in similar dental applications and are able to be disinfected using common bleach/water rinsing without deterioration. |
| Sterilization of Motor Exterior | Designed so that the exterior surface can be sterilized in a steam autoclave between each patient use. |
| Ultrasonic Scaler Safety (if included) | Provided with all accompanying labels and instructions for use from the original manufacturer's packaging. Additionally evaluated along with the entire system by Underwriter's Laboratories to internationally recognized safety standards for medical devices (ref UL 2601.1). |
| Performance - Handpiece Motor (Torque, Cooling, Connection) | More powerful electric Handpiece motor offers more torque and runs cooler than previous models. Uses the same methods for powering and connecting contra angles used in previously marketed devices (K882526/A). |
| Indications for Use / Intended Purpose | "Offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source." |
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 applicable to this type of device submission. There is no "test set" in the context of clinical data for performance evaluation as would be seen for an AI/CADe device. The assessment is based on engineering specifications, material properties, safety testing, and substantial equivalence claims to predicate devices.
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 is not applicable. There is no "ground truth" in the clinical sense mentioned in this 510(k) summary. The evaluation focuses on adherence to engineering standards and comparisons to physical properties of previously cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. No clinical test set requiring adjudication is described.
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 is not applicable. This device is a dental operative system, not an AI or imaging diagnostic tool. An MRMC study is not relevant to its type of evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. Performance is assessed against engineering standards (e.g., IEC 601.1, UL 2601.1) and by demonstrating substantial equivalence to predicate devices, not by clinical ground truth.
8. The sample size for the training set
This is not applicable. The device is not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. There is no training set mentioned or implied.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.