(157 days)
The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
The proposed device Dental Unit with Chair S2310 is a well equipped with two hands operation dental unit, which is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
The proposed device is modification device to Dental Unit with Chair S2318 (K080438). It and the existed device share the same intended use, similar configuration, safety and performance.
The proposed device consists of connection box, assistant holder, foot control, telescopic tray arm, instrument tray and operating light.
The provided text describes a 510(k) submission for a Dental Unit with Chair (Model S2310) and does not contain detailed information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Dental Unit with Chair S2318, K080438) through non-clinical bench testing and comparison of specifications.
Therefore, many of the questions regarding acceptance criteria, study design, sample size, ground truth, and expert involvement for AI/ML performance cannot be answered from the provided text.
Here's an analysis based on the information available:
Acceptance Criteria and Device Performance (as presented in the document)
The "acceptance criteria" in this context are implicitly met if the proposed device's performance aligns with relevant safety and technical standards and is substantially equivalent to the predicate device.
| Acceptance Criteria (Implied by adherence to standards and comparison to predicate) | Reported Device Performance (Proposed Device: Dental Unit with Chair S2310) |
|---|---|
| Safety and General Requirements (IEC 60601-1) | Complies with IEC 60601-1, Amendment 1, Amendment 2 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2: 2007 |
| Dentistry - Dental Units (General Requirements) (ISO 7494-1) | Complies with ISO7494-1: 2004 |
| Dentistry - Dental Units (Water & Air Supply) (ISO 7494-2) | Complies with ISO7494-2: 2003 |
| Dental Patient Chair (ISO 6875) | Complies with ISO 6875: 1995 |
| Sterilization of Health Care Products (ANSI/AAMI/ISO 17665-1) | Complies with ANSI/AAMI/ISO17665-1: 2006 |
| Intended Use | Identical to predicate: Supply power to and serve as a base for dental devices and accessories in a dental clinic/office setting. |
| Power Supply | 110V (Identical to predicate) |
| Frequency | 50/60Hz (Identical to predicate) |
| Power (with dental chair) | 400VA (Predicate: 600VA; difference discussed as not affecting safety/effectiveness) |
| Operating Light Power Supply | AC12V / 5W (Predicate: AC 12V / 50W; difference discussed as not affecting safety/effectiveness) |
| Operating Light Illumination | ≤20000lx (Predicate: Weak: ≤8000lx, Intense: ≥15000lx; difference discussed as not affecting safety/effectiveness) |
| Pressure of Water Supply | 0.2MPa-0.4MPa (Identical to predicate) |
| Air Supply Pressure | 0.6MPa-0.8MPa (Identical to predicate) |
| Dental Chair Loading Capacity | 200kg (Predicate: 135kg; difference discussed as not affecting safety/effectiveness) |
| Dental Chair Movement Range (Chair) | 390mm-740mm (Predicate: 410mm-750mm; difference discussed as not affecting safety/effectiveness) |
| Dental Chair Movement Range (Backrest) | 1°-70° (Predicate: 0°-70°; difference discussed as not affecting safety/effectiveness) |
| Dental Chair Movement Range (Headrest) | 150mm (Identical to predicate) |
| Attachable Accessories | Identical to predicate (e.g., High Speed Handpiece, Scaler, Dental Chair, etc.) |
| Operation Method | Identical to predicate (Control Panel, Assistant Control Panel, Foot Controller) |
The study that proves the device meets the acceptance criteria is the non-clinical bench testing comparing the proposed device to the predicate device and assessing compliance with various international standards. The document states: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards..."
Information Not Applicable or Not Provided in the Document:
The following information is typically relevant for AI/ML-driven medical devices but is not present in this submission, as it concerns a traditional medical device (Dental Unit with Chair) and not an AI/ML algorithm.
- Sample size used for the test set and the data provenance: Not applicable. This was a physical device undergoing bench testing, not an AI/ML model evaluated on a data set.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as understood in AI/ML (e.g., expert labels on images) is not a concept for this type of device submission. Compliance with standards and functional tests determined "truth."
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This type of study evaluates human performance with and without AI assistance, which is not relevant for a dental unit.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission was successful adherence to established engineering standards (e.g., IEC, ISO) and the functional specifications of the predicate device, demonstrated through bench testing.
- The sample size for the training set: Not applicable. This device does not use a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a 510(k) submission for a conventional medical device (Dental Unit with Chair) where "acceptance criteria" are met through compliance with established safety and performance standards and demonstrating substantial equivalence to a legally marketed predicate device via non-clinical bench testing. It does not involve AI/ML technology, and therefore, the related questions for AI/ML device evaluation are not addressed.
§ 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.